Incidence of liver events in patients with hepatitis B and C treated with rituximab

Abstract

8558 Background: Rituximab has been found to be effective in the treatment of patients with B-cell non-Hodgkin lymphomas. However, viral infections such as hepatitis B and C reactivation related to rituximab have been reported. Data on the effects of rituximab on patients with hepatitis B and C infection are limited. Methods: To investigate this topic, the records of 635 patients treated with rituximab in our institution between 1998 and 2006 were reviewed. A total of 49 patients with positive hepatitis serology was identified. Twenty seven patients had hepatitis B, 16 patients had hepatitis C and 6 patients had hepatitis B and C co-infection. Mild liver events were defined as an elevation of transaminases greater that twice the upper limit of normal. Severe liver events were defined as CT scan of the liver showing new or worsening signs of cirrhosis, liver biopsy showing evidence of necrosis, and death secondary to liver failure. Results: Twenty one (43%) patients developed one or more liver events. Median follow-up was 769 days. Elevation of transaminases occurred in 7 (26%), 8 (50%), and 4 (67%) patients with hepatitis B, C, and co-infection respectively. Three (11%) of patient with hepatitis B experienced viral reactivation. CT of the liver showing new or worsening cirrhosis occurred in 2 (7%), none, and 2 (33%) patients with hepatitis B, C, and co- infection respectively. Liver biopsy showing evidence of necrosis was present in 1 (4%) patient with hepatitis B. Death secondary to liver failure occurred in 3 (11%), none, and 1 (17%) patients with hepatitis B, C, and co-infection respectively. The overall number of severe liver events was 4 (15%), none, and 3 (50%) for patients with hepatitis B, C, and co-infection respectively (p=0.01). Baseline total bilirubin and albumin levels were observed to be significant predictors of severe adverse events. Conclusions: Treatment of patients with hepatitis B with rituximab requires careful monitoring for severe hepatic complications, especially if there is hepatitis C co-infection or evidence of baseline liver dysfunction. Rituximab appears to be safe in patients with hepatitis C. No significant financial relationships to disclose.